cobas® WNV

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Highly sensitive WNV test

Detects West Nile Virus RNA in human plasma for an extra level of safety all-year long

The cobas® WNV Test is a real-time polymerase chain reaction (PCR) test to detect West Nile virus (WNV) for use on the cobas® 6800/8800 Systems.

Features and benefits

Features of the cobas® WNV Test

  • Detection of both WNV lineages 1 and 2
  • Broad screening utility: whole blood, blood components, and cadaveric* (non-heart beating) organs and tissues

* CE-IVD only, please review Instructions for Use for full details

Results in real-time for testing you can trust

  • Ready-to-use reagents - no thawing, pouring or mixing required
  • Stabilized real-time PCR reagents do not require calibration
  • Full-process internal control helps ensure result integrity
  • cobas® WNV Control Kit provides true external positive controls that have no effect on result calculation
  • Can be run simultaneously with other assays on the cobas® 6800/8800 Systems

Markedly reduce the risk of transfusion transmission

Designed to run on the cobas® 6800/8800 System, the cobas® WNV Test allows donor screening laboratories to maximize blood safety, with full process internal and external positive controls, while reducing hands-on time with full automation at every step.

Intended use

Intended use

The cobas® WNV test is a qualitative in vitro test for the direct detection of West Nile Virus (WNV) RNA in human plasma.

This test is intended for use to screen donor samples for WNV RNA in plasma samples from individual human donors, including donors of whole blood and blood components, as well as other living donors. This test is also intended for use to screen organ and tissue donors when donor samples are obtained while the donor’s heart is still beating and in testing of cadaveric (non-heart beating) donors.
This test is not intended for use on samples of cord blood.

Plasma from all donors may be screened as individual samples. For donations of whole blood and blood components, plasma samples may be tested individually or may be tested in pools comprised of aliquots of individual samples. For donations from cadaveric (non-heart beating) organ and tissue donors, samples may only be screened as individual sample. This test is not intended for use as an aid in diagnosis of WNV infection.

cobas® WNV for use on cobas® 6800 and cobas® 8800 Systems is a qualitative in vitro nucleic acid screening test for the direct detection of West Nile virus (WNV) RNA in human plasma.

This test is intended for use to screen donor samples for WNV RNA in plasma samples from individual human donors, including donors of whole blood and blood components, as well as other living donors. This test is also intended for use to screen organ and tissue donors when donor samples are obtained while the donor’s heart is still beating.

Plasma from all donors may be screened as individual samples. For donations of whole blood and blood components, plasma samples may be tested individually or in pools comprised of not more than six individual samples.

This test is not intended for use as an aid in diagnosis of WNV infection.
This test is not intended for use on samples of cord blood.
This test is not intended for use on cadaveric blood specimens.

Registration status

CE-IVD, US-IVD

Package inserts

Access package inserts through your country’s Roche Diagnostics Website.

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